510(k) Report

FDA applicant

Ami-Med Corp.

Irvine, CA1 decision1993–19930 recalls

FDA records 1 decision for Ami-Med Corp. (Irvine, CA) in 1993: 1 510(k) clearance. All are in product code DYG (Catheter, Flow Directed). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ami-Med Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ami-Med Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ami-Med Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYGCatheter, Flow Directed1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K925444Cardiac Output Pulmonary Artery Catheter & MonitorAmi-Med Corp. · 19931cites it

What has FDA decided for it lately?

  • K925444Cardiac Output Pulmonary Artery Catheter & MonitorAmi-Med Corp. · 1993

The one decision as Ami-Med Corp. →